Simultaneous National Scientific Advice
by Maria Schacker
Scientific advice (SA) is an important regulatory tool for companies developing medicinal products to communicate with regulators and receive feedback and input on their drug development program. It ensures that appropriate test and studies are performed and data are presented adequately for a successful regulatory submission, like a clinical trial application (CTA) or marketing authorization application (MAA). SA can be obtained centrally from EMA, as well as on a national level from the national competent authorities (NCAs) and typically concerns questions around quality, nonclinical, clinical and/or regulatory requirements.
Companies often seek national SA from more than one NCA and until recently this had to be done by separate requests and meetings. This is not only resource intensive, but also requires careful planning and a thought-through sequential SA approach to maximize the feedback from all regulatory agencies. However, this could now be changing: Since 1st February 2020 the EU-Innovation Network is running a pilot for simultaneous national scientific advice (SNSA), which makes it possible to receive SA from two NCAs at the same time.
In addition to the advantages for applicants, such as receiving aligned, consolidated views from NCAs that initially may have had divergent regulatory positions, and identifying early on if there are issues that may require discussion centrally at EMA, the SNSA procedure also offers advantages to NCAs within the European regulatory network. It gives regulators the chance to discuss and increase awareness for different regulatory positions and expectations. Furthermore, it is a great platform for the exchange of knowledge and expertise between them.
The SNSA procedure is very similar to that of single national SA and the key steps are outlined in Figure 1. After selecting two NCAs the applicant should send an informal letter of intent (and application form if applicable) to one of the two NCAs, stating that this is a request for SNSA and indicating the chosen second NCA. When choosing the two NCAs applicants should be aware and consider that individual agency requirements also apply to SNSA procedures, including for example submission timelines, scope of the advice or content and length of the briefing documents. Once both agencies have accepted the request, one of the two will take the lead and coordinate the procedure, including communication with the applicant, agreement on timelines and organization of the meeting. After the briefing documentation is submitted to both NCAs, and they have validated and reviewed the package, the SNSA meeting typically takes place as a face-to-face meeting between the applicant and the coordinating NCA, with the second NCA joining by tele- or videoconference. Both NCAs will aim to come to a mutual agreement and their formal opinions will be reflected in the final advice letter. In case one of the two selected NCAs does not accept the request for SNSA, the applicant can suggest an alternative NCA, withdraw the request or decide to receive standard SA from the other NCA.
The initial pilot phase will run until the end of 2020 and includes the following 12 NCAs: AEMPS (Spain), AGES (Austria), AIFA (Italy), BfArM (Germany), FAMHP (Belgium), FIMEA (Finland), MHRA (UK), NOMA (Norway), OGYEI (Hungary), PEI (Germany), SUKL (Czech Republic) and URPL (Poland). Depending on the demand from pharmaceutical companies for SNSA and the feedback from the NCAs involved in this pilot, the procedure may be extended to involve additional NCAs and offer the possibility to receive advice from more than two NCAs at the same time.
At Biopharma Excellence we have substantial experience preparing and conducting successful national scientific advice procedures. This includes identifying the right questions, writing and compiling the briefing package and participating in the agency meetings. We at Biopharma Excellence are happy to support your SA and SNSA procedures and help you to have successful agency interactions. To learn more about our services in this area, please contact us.